Ethanol Locks for the Treatment of Central Venous Line Infections

This study has been terminated.
(inability to enroll adequate number of patients)
Sponsor:
Information provided by (Responsible Party):
christine mckiernan, Baystate Medical Center
ClinicalTrials.gov Identifier:
NCT00680459
First received: May 16, 2008
Last updated: January 29, 2014
Last verified: January 2014
Results First Received: September 3, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Treatment
Condition: Bloodstream Infection
Interventions: Drug: 70% ethanol
Drug: heparin flush solution

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
70% Ethanol Solution 70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
Heparin Flush heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.

Participant Flow:   Overall Study
    70% Ethanol Solution     Heparin Flush  
STARTED     7     6  
COMPLETED     7     6  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
70% Ethanol Solution 70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
Heparin Flush heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
Total Total of all reporting groups

Baseline Measures
    70% Ethanol Solution     Heparin Flush     Total  
Number of Participants  
[units: participants]
  7     6     13  
Age  
[units: participants]
     
<=18 years     7     6     13  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  7.4  ± 4.96     6.33  ± 4.0     6.9  ± 4.4  
Gender  
[units: participants]
     
Female     3     2     5  
Male     4     4     8  
Region of Enrollment  
[units: participants]
     
United States     7     6     13  



  Outcome Measures
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1.  Primary:   Clearance of Central Venous Line Infection by Day 6 of Study   [ Time Frame: 6 days ]

2.  Secondary:   Preservation of Central Venous Line (Line Not Requiring Removal) by Day 35 of Study   [ Time Frame: 35 days ]

3.  Secondary:   Recurrence of Central Venous Line Infection Within 35 Days of Enrollment   [ Time Frame: 35 days ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Dr. Christine McKiernan
Organization: Baystate Medical Center
phone: 413-794-5370
e-mail: Christine.McKiernan@bhs.org


Publications:

Responsible Party: christine mckiernan, Baystate Medical Center
ClinicalTrials.gov Identifier: NCT00680459     History of Changes
Other Study ID Numbers: IRB08-064
Study First Received: May 16, 2008
Results First Received: September 3, 2013
Last Updated: January 29, 2014
Health Authority: United States: Institutional Review Board